Inclusion Criteria:

1. Histological or cytological documented diagnosis of inoperable, locally advanced,
recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.

2. Patients must have evidence of disease but measurable disease is not mandatory.

3. 18 years of age or older.

4. ECOG performance status of 0 - 3.

5. Life expectancy of at least 12 weeks.

6. Patients who received one or two previous line of systemic chemotherapy irrespective
of EGFR mutation status.

7. No more than 2 prior chemotherapy regimens are permissible. Patients must have
recovered from any toxic effects and at least 3-4 weeks must have elapsed from the
last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids
or gemcitabine). Patients who, in the opinion of the investigator, have fully
recovered from surgery in less than 4 weeks may also be considered for the study.
Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.

8. Patients are eligible to receive Erlotinib (TarcevaTM) as first line if they met one
of the following criteria:

1. Positive EGFR mutation tested in certified lab (although EGFR test is not
mandatory only if available).

2. Poor performance status of 3

3. Severe co morbidities and illness which make the patient not candidate for
standard systemic chemotherapy .

9. .Patient with negative EGFR mutation are still candidate for 2nd and 3rd line therapy
(although EGFR test is not mandatory only if available).

10. Prior radiotherapy is allowed.

11. Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L.

12. Serum bilirubin must be < 1.5 upper limit of normal (ULN).

13. AST and ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis).

14. Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min.

15. Able to comply with study and follow-up procedures.

16. For all females of childbearing potential a negative pregnancy test must be obtained
within 72 hours before starting therapy. Patients with reproductive potential must
use effective contraception.

17. Signed Informed Consent to participate in the study.

Exclusion Criteria:

1. Any unstable systemic disease (including active infection, grade 4 hypertension,
unstable angina, congestive heart failure, hepatic, renal or metabolic disease).

2. Prior therapy with systemic anti-tumor therapy with HER1/EGFR inhibitors (as small
molecule or monoclonal antibody therapy).

3. Any other malignancies within 5 years (except for adequately treated carcinoma in
situ of the cervix or basal or squamous cell skin cancer).

4. Patients are excluded if they have brain metastasis or spinal cord compression that
is newly diagnosed and/or has not yet been definitively treated with surgery and/or
radiation; previously diagnosed and treated CNS metastases or spinal cord compression
with evidence of stable disease (clinically stable imaging) for at least 2 months is
permitted.

5. Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjogren syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions. The use of
contact lenses is not recommended during the study. The decision to continue to wear
contact lenses should be discussed with the patient's treating Oncologist and the
ophthalmologist.

6. Patients who cannot take oral medication, who require intravenous alimentation, have
had prior surgical procedures affecting absorption, or have active peptic ulcer
disease.

7. Nursing mothers.